Table 5Outcomes from trials in children with perennial allergic rhinitisa

Author
Year
Quality
Drug dosage
Number of subjects
Mean age
Range (years)
Length of follow- up (weeks)Total Symptom ScoreOther outcomes
Head-to-head trials
Sienra-Monge
1999110

Fair
C: cetirizine 0.2 mg/kg qd
L: loratadine 0.2 mg/kg qd

N=80
4.4
2–6
4NRGlobal Evaluation Score assessed by investigator: (C vs. L): −62.8% vs. −64.6% (NSD)
Parent assessment of patient symptoms: C more effective in relieving rhinorrhea, sneezing, nasal obstruction, and nasal pruritus (P<0.001)
Lee 2009114

Fair
C: cetirizine 10 mg
L:
Levocetirizine 5
mg
P: Placebo

N=80
8
6–12
12C: −5.54 (P<0.05 vs. levocetirizine)
L: −3.30
P: −0.18
Both treatment groups better than placebo
Both treatment groups improved quality of life vs. placebo, but no difference between treatment groups.
Active-control trials
Hsieh
2004107

Fair
C: cetirizine 20 mg qd
M: montelukast
5 mg qd
P: placebo qd

N=65
8.1
6–12
12TSS: C<M<P weeks 4,8,12 (P<0.05)
Mean rhinorrhea score C and M<P weeks 4, 8, 12 (P<0.01), C<M weeks 8 and 12 (P<0.01)
Nasal itching and sneezing C<P weeks 4, 8, 12, (P<0.05)
Quality of life:
Improved in C and M more than in P at 12 weeks
(P<0.01)
Lai
2002109

Fair
C: cetirizine 10mg qd
K: ketotifen 1 mg bid
O: oxatomide 1 mg/kg bid
P: placebo

N=80
8.07
6–12
12C, K, and O improved mean TSS from baseline compared to P at 12 wk (P<0.01)
Lower TSS for C than K and O for week 12 (P<0.05)
C, K and O all demonstrated improved individual symptom scores compared to P, and results were generally significant (P<0.05)
Quality of life: higher for C and K at 12 weeks (P<0.05 vs. P)
Placebo-controlled trials
Baelde
1992104

Fair
C1: cetirizine 5.0 mg bid
C2: cetirizine 2.5 mg bid
P: placebo bid

N=138
8.6
2–14
2Mean % change from baseline, assessed by investigator (C1 vs. C2 vs. P) Nasal obstruction: −47.9% vs. −33.2% vs. −28.7% (C1 vs. P, P=0.03)
Rhinorrhea: 59.4% vs. 47.3% vs. 37.9% (C1 vs. P, P=0.03)
Sneezy: 68.2% vs. 47.3% vs. 37.9% (C2 vs. P, P=0.04)
Pharyngeal drip: 77.2% vs. 53.2% vs. 54.9% (C1 vs. C2, P=0.03)
Nasal pruritus: NSD, data not reported
Overall average score for all symptoms: C1 vs. P, P=0.01
Global evaluation by investigators:
C1 > C2 (P=0.04)
C1 > P (P=0.006)

Evaluation by parents: C1 vs. P and C2 vs. P, both NSD
Ciprandi
2001105

Fair
C: cetirizine 5 mg qd
P: placebo qd

N=20
6.5
3–10
24Weekly mean rhinitis scores: C< P for 24/24 weeks; between-group difference significant for 11/24 weeks (P<0.05)
Weekly mean asthma symptom scores: C <P for 6/24 weeks (P<0.05); for 10/24 weeks P<C (NSD); for 8/24 weeks C=P
Jobst
1994108

Fair
C1: cetirizine 2.5 mg qd
C2: cetirizine 5 mg qd
C3 cetirizine 10 mg qd
P: placebo qd

N=330
NR
6–12
2Investigator-assigned severest symptom scores:
between-group differences, week 2 (P=0.052), P had highest score; NSD among C1, C2, and C3 at end week 2
Over time patient’s severest symptom score decreased in all groups, most marked for C3, least marked for P
Considering patient’s severest symptom (% days asymptomatic):
C3>P (P=0.008), NSD C1 vs. P and C2 vs. P
% days when symptoms were absent or mild:
C3>P (P=0.016), NSD C1 vs. P and C2 vs. P
% days when no severe symptoms: C1>P (P=0.012), C2>P (P=0.006), C3>P (P=0.002)
Yang
2001111

Fair
L: loratadine syrup 5 mg if < 30 kg, 10 mg if >30 kg
P: placebo

N=46
6.3
3–12
Mean % change in investigator-assessed TSS from baseline, L vs. P
Day 21: −42.2% vs. −22.7% (P=0.063)
% decrease in patient- evaluated TSS from baseline
Week 3: −13.2% vs. −5.6% (P=0.014)

Abbreviations: bid, twice daily; NR, not reported; NSD, no significant difference; NS, not significant; qd, once daily; tid, 3 times daily; TSS, Total Symptom Score; wk, week.

a

Only fair- and good-quality studies are presented in the table. Poor-quality studies are listed in Appendix F.

From: Results

Cover of Drug Class Review: Newer Antihistamines
Drug Class Review: Newer Antihistamines: Final Report Update 2 [Internet].
Carson S, Lee N, Thakurta S.
Portland (OR): Oregon Health & Science University; 2010 May.
Copyright © 2010 by Oregon Health & Science University, Portland, Oregon 97239. All rights reserved.

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